510(k) · Cleared
ClearedApex (TM) Prostatic Balloon Dilation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peripheral Systems Group · KOE Dilator, Urethral
Cleared on Dec 27, 1991 after a 144-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Dec 27, 1991
- Review
- 144 days
- Class
- Class II
- Product code
- KOE
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK913477 Apex (TM) Prostatic Balloon Dilation CatheterPeripheral Systems Group · 1991
- Descendant · cites it directly · 0 of its ownK991847 Thermoflex SystemArgomed, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K991847Thermoflex SystemArgomed, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K913477 | Apex (TM) Prostatic Balloon Dilation Catheter | Peripheral Systems Group | 1991 | — |
| +1 | K991847 | Thermoflex System | Argomed, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOE device
- #1 K191061 Optilume Basic Urological Balloon Dilation…score -0.8 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991847 | Thermoflex System | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991847 (Argomed, Inc., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KOE devicesKOE Dilator, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KOE
Too few KOE 510(k)s in any year since 2007 to give a median.
Recalls per year · KOE
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOE
11in 2025
MAUDE reports naming product code KOE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 2 | 20 |
| 2020 | 1 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K913477 · printed Nov 4, 2026
Cite this page
510(k) Report. “K913477: Apex (TM) Prostatic Balloon Dilation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K913477
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026